Study to Evaluate Immunogenicity, Safety, and Tolerability of Zostavax™ Vaccine (Zoster Vaccine Live, V211) Administered Concomitantly Versus Nonconcomitantly With Quadrivalent Influenza Virus Vaccine (Inactivated) in Participants >=50 Years of Age (V211-062)
| Status: | Completed |
|---|---|
| Conditions: | Shingles, Infectious Disease |
| Therapuetic Areas: | Dermatology / Plastic Surgery, Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 50 - Any |
| Updated: | 11/28/2015 |
| Start Date: | September 2015 |
| End Date: | February 2016 |
| Contact: | Toll Free Number |
| Phone: | 1-888-577-8839 |
A Phase III, Double-Blind, Randomized, Multicenter Study to Evaluate the Immunogenicity, Safety, and Tolerability of ZOSTAVAX™ Administered Concomitantly Versus Nonconcomitantly With Quadrivalent Influenza Virus Vaccine (Inactivated)
The study will evaluate immunogenicity, safety, and tolerability of Zostavax™ Vaccine (V211)
administered concomitantly versus nonconcomitantly with Quadrivalent Influenza Virus vaccine
(inactivated) in participants >=50 years of age. The primary hypotheses will test the
non-inferiority of concomitant versus nonconcomitant vaccination with regard to 1) Varicella
zoster virus (VZV) Geometric Mean Titer (GMT) antibody responses and 2) influenza virus
strain-specific GMT antibody responses, and 3) acceptability of VZV GMT antibody responses
after concomitant vaccination.
administered concomitantly versus nonconcomitantly with Quadrivalent Influenza Virus vaccine
(inactivated) in participants >=50 years of age. The primary hypotheses will test the
non-inferiority of concomitant versus nonconcomitant vaccination with regard to 1) Varicella
zoster virus (VZV) Geometric Mean Titer (GMT) antibody responses and 2) influenza virus
strain-specific GMT antibody responses, and 3) acceptability of VZV GMT antibody responses
after concomitant vaccination.
Inclusion Criteria:
- History of varicella or residence in a VZV-endemic area for >=30 years
- Male, female not of reproductive potential, or female of reproductive potential and
has a negative pregnancy test and agrees to avoid becoming pregnant throughout the
study
Exclusion Criteria:
- History of hypersensitivity to any vaccine component
- Previously received any varicella or zoster vaccine
- Received an influenza vaccine for the 2015-16 season
- History of Herpes zoster
- Received immunoglobulin, monoclonal antibodies, or any blood products within 5 months
before study vaccination
- Pregnant or breastfeeding
- Known or suspected immune dysfunction
- Experienced Guillain-Barré syndrome within 6 weeks
- Severe thrombocytopenia or any other coagulation disorder
We found this trial at
28
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